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LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.

The provided document is a 510(k) summary for the LapBag®, a sterile specimen retrieval pouch. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested fields related to AI performance, expert ground truth, adjudication, and clinical study details cannot be filled directly from this document. The document describes engineering and biocompatibility tests to ensure the device itself is safe and performs as intended compared to a predicate, not clinical accuracy or AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for performance similar to how an AI algorithm would be evaluated. Instead, it lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices."

Study Proving Device Meets Acceptance Criteria:
The study described is a series of laboratory and bench tests comparing the LapBag® to a predicate device (MGB Disposable Retrieval Bag/LAPBAG, K093194). The objective was to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel medical AI algorithm. The tests show the LapBag® is comparable in physical, mechanical properties, and biocompatibility. The main difference highlighted is that LapBag® has a wider range of pouch sizes, and comparison tests (Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test) were performed to confirm equivalence despite this difference.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical data or AI evaluation. The "tests" mentioned are engineering and material verification tests.

• Sample Size: Not explicitly stated for each test, but standard statistical sampling would be used for material and product testing.
• Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based and conducted by the manufacturer, Sejong Medical Co., Ltd. (Republic of Korea).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this type of device (a surgical retrieval bag). The "ground truth" for the material and performance tests would be the established scientific and engineering principles and standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in clinical studies, typically for diagnostic or screening devices. This is a material and performance validation for a surgical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this device. This is a surgical accessory, not a diagnostic imaging device or AI algorithm intended to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests, the "ground truth" is defined by:

• International standards (e.g., ISO 11737-1, ISO 10993 series).
• Established scientific and engineering principles for material strength, leak integrity, and biocompatibility.
• Comparison to the performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

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The MGB LAPBAG sterile retrieval bag for Endoscopic surgery is intended to be used for:

• -General surgery
• Abdominal surgery - .
• Gynecological surgery -
• Thoracic minimally invasive procedures. -

The Specimen Retrieval Bag is indicated for use in endoscopic procedures to allow tissues or debris to be removed from the abdominal cavity.

Not Found

I am sorry, but the provided document does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to MGB Endoskopische Geräte GmbH Berlin regarding their MGB Disposable Retrieval Bag/LAPBAG. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, study methodologies, or ground truth details.

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